RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a Pennsylvania-based biopharmaceutical company, recently announced it has completed enrollment for its Phase 2b/3 study of NRX-101. This patented combination of D-cycloserine, an NMDA antagonist, and lurasidone could potentially revolutionize treatment for suicidal treatment-resistant bipolar depression.
The trial’s enrollment exceeded the initial target, with 74 patients enrolled compared to the anticipated 70. The over-enrollment was strategic, aimed at enhancing the statistical power of the study. A positive outcome from this trial would trigger a milestone payment from Alvogen, which will then assume responsibility for further development and commercialization costs for this program.
According to Dr. Jonathan Javitt, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, NRX-101 is potentially the first oral medication to have shown reduced suicidal ideation in patients with bipolar depression. “We hope to bring a lifesaving home-use oral medicine to patients whose only currently-approved treatment is electroconvulsive therapy (ECT),” he added.
The Phase 2b/3 trial, conducted under the supervision of Principal Investigator Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital, is a double-blind study comparing NRX-101 to lurasidone over a period of six weeks. The primary efficacy endpoint is the reduction in depression as measured on the MADRS scale, while the secondary endpoint is the reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS).
The company also revealed that treatment compliance and concordance of local raters to central raters scores were above 94%, a figure that surpasses the industry standard typically observed in CNS trials.
Top-line results from this groundbreaking study are expected later this quarter. If successful, NRX-101 could provide a new, potentially life-saving treatment option for patients with treatment-resistant bipolar depression, a condition that currently has limited approved treatments. The implications of this research are significant, not just for NRx Pharmaceuticals and its investors, but also for the broader pharmaceutical industry and, most importantly, the many patients living with this severe form of depression.
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